| 摘要 |
The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, an antioxidant, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In some embodiments, the additive is a liquid. In other embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide or ester groups. |
| 主权项 |
1. A balloon catheter for delivering a therapeutic agent to a tissue, the balloon catheter being sterilized from exposure of the balloon catheter to ethylene oxide and comprising a coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent, an antioxidant and an additive, wherein:
the therapeutic agent is chosen from paclitaxel, rapamycin, or combinations thereof; the antioxidant is butylated hydroxyanisole; the additive is chosen from PEG-20 sorbitan monooleate, PEG-20 sorbitan monolaurate, PEG-15 2-hydroxystearate, oleth-10, oleth-20, PEG-b-PLA, dioctyl sodium sulfosuccinate, sodium dodecyl sulfonate, polyvinylpyrrolidone, PEG-35 castor oil, sorbitol, lecithin, butyral trihexyl citrate, aleuritic acid, shellolic acid, or combinations thereof; and none of the therapeutic agent in the coating layer is hydrolyzed or oxidized. |
